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Let's push the boundaries together and make the most of your talents!

Senior or Principal Medical Writer

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Clinical Development
Job ID:  68868

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Senior or Principal Medical Writer
UCB – Inspired by patients. Driven by science.
Help us transform patients’ lives.

 

To strengthen our Global Clinical Science & Operations Group, we are looking to fill the position of: Senior or Principal Medical Writer

 

About the Role
You will be responsible for:
•    Ensuring critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation.
•    Preparing clinical submission documents for a regulatory audience, within a team environment, according to UCB SOPs and templates.
•    Managing review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner. Provide process, content, and submission/document planning expertise to Clinical Submission Team, Clinical Satellite Team, and Clinical Trial Team. Advise team on resource utilization, efficiencies, timelines, and interdependencies.

 

About You
You should have:
•    Expert knowledge of medical, pharmaceutical, and clinical research concepts.
•    The ability to exercise independent judgment in developing methods, techniques, and
evaluation criteria for obtaining results.
•    A high degree of familiarity with statistical and data output.
•    Expert knowledge of the methods, techniques, and procedures of medical writing tasks.
•    Prior CSR and Summary Document generation experience, preferably at a sponsor.
•    Prior experience with submissions in Common Technical Document (CTD) format.
•    Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management). 
•    Detailed and experienced-based understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content.
•    Detailed and experience-based understanding of applicable regulations and guidelines (e.g., Code of Federal Regulations, European Directive, and International Conference on Harmonisation).

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Apply now »